Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050514
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NATACYN NATAMYCIN 5% SUSPENSION;OPHTHALMIC Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/30/1978 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2008 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050514s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050514s009ltr.pdf
10/19/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/02/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1992 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/30/1992 SUPPL-4 Labeling

Label is not available on this site.

03/08/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2008 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050514s009lbl.pdf

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